Lupus NephritisPhase 1/2NCT00709722
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
A Phase 1/2 study testing NKT-01 in people with Lupus Nephritis, run by Nippon Kayaku Co., Ltd. at 6 sites in 2 countries.
Trial summary
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- NKT-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2003to Apr 2007
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-70 years.
- A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).
- Sufficient signs to diagnose active SLE nephritis.
- Serum creatinine concentration of <= 5.0 mg/dL.
- Leucocyte counts >= 4000/uL.
- Receiving OCS (<= 1.0 mg/kg/day; a maximum dose of 80 mg/day).
- Prior treatment with cyclophosphamide, azathioprine, cyclosporin A, or any other immunosuppressive drugs.
Who cannot join
- Chronic infection of HIV, Hepatitis B, Hepatitis C.
- Acute infection including fungal, viral, bacterial or protozoal diseases.
- Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin > 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N).
- Pregnant or lactating women
- Female patients of child bearing age without safe method of contraception.
- Anemia (hemoglobin < 8.0 g/dL), leucopenia (leucocytes < 4000/uL unless attributable to SLE: leucocytes < 2000/uL), thrombocytopenia (platelets < 50000/uL).
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- Neutrophils below 1000/uL.
- Hypogammaglobulinemia below 400 mg/dL of serum IgG.
- Any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system are not allowed to be included into the study.
- History of malignancy.
- Current participation in another trial or lass than 6 months since participation in a similar trial.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Universitatsklinikum Charite
Berlin, 10117
Universitat Frankfurt
Frankfurt, 60590
University of Heidelberg
Heidelberg, 69120
University Hospital Mannheim, Heidelberg University
Mannheim, 68135
University of Regensburg
Regensburg
About this study
Official title: Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
Read the detailed description
The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- NKT-01
- Keywords
- Lupus nephritis, Deoxyspergualin, Immunosuppression
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKT-01Drug
Also called Deoxyspergualin, gusperimus
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NKT-01 Receives: Drug: NKT-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and Partial Response Rate
A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.
Measured: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks
Secondary outcomes (2)
SELENA-SLEDAI Score
The "Safety of Estrogen in Lupus Erythematosus National Assessment - systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.
Measured: Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks
Treatment Days With Corticosteroids of <= 7.5 mg/Day
Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).
OCS dosage was maintained, decreased or increased according to the response to DSG.
The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle.
Measured: 1st and 9th Cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startOct 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanns-Martin Lorenz, Professor, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709722
- Sponsor's protocol ID
- SLE01-ENK
- Status last verified
- Jul 2008
- First submitted
- 2 Jul 2008
- Last updated
- 10 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lorenz HM, Schmitt WH, Tesar V, Muller-Ladner U, Tarner I, Hauser IA, Hiepe F, Alexander T, Woehling H, Nemoto K, Heinzel PA. Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study. Arthritis Res Ther. 2011 Mar 1;13(2):R36. doi: 10.1186/ar3268.
PubMed 21356124
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT00709722
- Acronym / sponsor ID
- SLE01-ENK
- Conditions
- Lupus Nephritis
- Keywords
- Lupus nephritis, Deoxyspergualin, Immunosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
Detailed description
The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NKT-01NKT-01 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 18-70 years.
- A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).
- Sufficient signs to diagnose active SLE nephritis.
- Serum creatinine concentration of <= 5.0 mg/dL.
- Leucocyte counts >= 4000/uL.
Key exclusion criteria (11 listed)
- Chronic infection of HIV, Hepatitis B, Hepatitis C.
- Acute infection including fungal, viral, bacterial or protozoal diseases.
- Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin > 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N).
- Pregnant or lactating women
- Female patients of child bearing age without safe method of contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKT-01Also: Deoxyspergualin, gusperimusSC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles. | Drug | 1 |
Primary outcome
Complete and Partial Response Rate
Time frame: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks
A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.
2 secondary outcomes
SELENA-SLEDAI Score
Time frame: Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks
Treatment Days With Corticosteroids of <= 7.5 mg/Day
Time frame: 1st and 9th Cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21356124Lorenz HM, Schmitt WH, Tesar V, Muller-Ladner U, Tarner I, Hauser IA, Hiepe F, Alexander T, Woehling H, Nemoto K, Heinzel PA. Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study. Arthritis Res Ther. 2011 Mar 1;13(2):R36. doi: 10.1186/ar3268.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanns-Martin Lorenz, Professor principal investigator
Heidelberg University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NKT-01 in people with Lupus Nephritis, run by Nippon Kayaku Co., Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete and Partial Response Rate (time frame: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.